(116 days)
Used for extraoral etching of various types of resin bonded porcelain/ceramic restorations (veneers, crowns, and inlays) prior to the bonding and cementation procedure.
HF-Etchant Hydrofluoric Acid Etching Gel is composed of water, hydrofluoric acid, thickening agent and pigment. It is a water soluble and miscible flowable gel. Using a disposable dispensing tip, the Hydrofluoric acid etching gel can be directly applied onto the porcelain/ceramic surface. Its color is red, which can be identified easily on tooth or a repairing surface with contrast. HF-Etchant Hydrofluoric Acid Etching Gel is delivered in syringes.
Here's a breakdown of the requested information, based on the provided FDA 510(k) summary for the HF-Etchant Hydrofluoric Acid Etching Gel.
Important Note: The provided document is a 510(k) summary for a medical device (HF-Etchant Hydrofluoric Acid Etching Gel), not an AI/ML-based medical device. Therefore, many of the requested fields related to AI/ML studies (like expert adjudication, MRMC studies, training/test set sample sizes, and ground truth establishment for AI) are not applicable to this type of submission and will be marked as such. The device described is a chemical etching gel, not a software algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Internal Standard SOP) | Reported Device Performance |
|---|---|
| Thermostability | Qualified |
| Hydrofluoric acid content | Qualified |
| Rotational viscosity value | Qualified |
| pH value | Qualified |
| Shelf Life (2-year real-time stability) | Reliable and Effective |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified for formal "test sets" as would be done for an AI/ML algorithm. The performance was determined through internal testing of the device itself.
- Data Provenance: Not explicitly stated, but the testing was "according to Internal standard SOP of the company." This implies in-house testing by Rizhao HuGe Biomaterials Company, Ltd. (China).
- Retrospective or Prospective: Not applicable in the context of an AI/ML algorithm. The performance testing appears to be prospective (i.e., conducted on the manufactured device).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. This is a chemical device, not an AI/ML system requiring expert-established ground truth for a test set. The "ground truth" for its properties (like pH, viscosity) is determined by standard chemical and physical measurement techniques.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI/ML device. An MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is not an algorithm.
7. The Type of Ground Truth Used
- For physical and chemical properties (Thermostability, Hydrofluoric acid content, Rotational viscosity value, pH value): The ground truth is established by quantitative measurements against the company's internal standard operating procedures (SOPs).
- For shelf life: The ground truth is established through real-time stability testing over a 2-year period.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
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December 20, 2024
Rizhao HuGe Biomaterials Company, Ltd. Maggie Zheng Regulatory Affairs Manager No.2 North Zhaoyang Road, District of Donggang Rizhao City, 276800 CHINA
Re: K242530
Trade/Device Name: HF-Etchant Hydrofluoric Acid Etching Gel Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE, EIH, PME Dated: August 24, 2024 Received: August 26, 2024
Dear Maggie Zheng:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
MICHAEL E. ADJODHA -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
HF-Etchant Hydrofluoric Acid Etching Gel
Indications for Use (Describe)
Used for extraoral etching of various types of resin bonded porcelain/ceramic restorations (veneers, crowns, and inlays) prior to the bonding and cementation procedure.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K242530
510 (k) Summary
This summary of 510(k) for the subjective device equivalence information is being submitted in accordance with the requirements of 21 C.F.R. 807.92.
1. Date Summary Prepared: December 19, 2024
2. Submitter Information:
| Owner's Name | Rizhao HuGe Biomaterials Company, Ltd. |
|---|---|
| Address | No.2 North Zhaoyang Road, District of Donggang, Rizhao City,Shandong Province, China 276800 |
| Telephone | 0086 633 2277268 |
| Fax | 0086 633 2277298 |
| Contact Person | Ms. Maggie Zheng |
| Contact Title | Regulatory Affairs Manager |
| zhengxy@hugedent.com |
3. Device Name
Trade name: HF-Etchant Hydrofluoric Acid Etching Gel Common name: Hydrofluoric Acid Etching Gel Classification name: Resin Tooth Bonding Agent (21 CFR 872.3200) Regulatory Class: II Product Code: KLE, EIH, PME
4. Predicate Device Information
| Owner/Operator | Device Trade Name | 510 (k) No. | Product Code |
|---|---|---|---|
| Liaoning Upcera Co., Ltd | Ceramic Etchant (HF-5 andHF-9) | K240153 | KLE, EIH, PME |
No reference device were used in this submission.
5. Description of Device
HF-Etchant Hydrofluoric Acid Etching Gel is composed of water, hydrofluoric acid, thickening agent and pigment. It is a water soluble and miscible flowable gel. Using a disposable
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dispensing tip, the Hydrofluoric acid etching gel can be directly applied onto the porcelain/ceramic surface. Its color is red, which can be identified easily on tooth or a repairing surface with contrast.
HF-Etchant Hydrofluoric Acid Etching Gel is delivered in syringes.
6. Indications for Use
Used for extraoral etching of various types of resin bonded porcelain/ceramic restorations (veneers, crowns, and inlays) prior to the bonding and cementation procedure.
7. Technological Characteristics Comparison
All components of the subject device are based upon industry well-known chemistry. The following table shows the significant technological characteristics for the subject device and indicates the following similarities and differences with the predicate device.
| TechnologicalCharacteristics | Subject device(HF-Etchant Hydrofluoric Acid EtchingGel) | Predicate deviceK240153 |
|---|---|---|
| Compositionof Materials | Water, hydrofluoric acid, thickening agentand pigment. | Water, hydrofluoric acid, thickening agentand pigment. |
| Indications of Use | Used for extraoral etching of varioustypes of resin bonded porcelain/ceramicrestorations (veneers, crowns, and inlays)prior to the bonding and cementationprocedure. | Ceramic Etchant is intended for etchingthe porcelain veneers, crowns, and inlaysextraorally. It is also used for pretreatingthe porcelain veneers, crowns, and inlaysextraorally before bonding. |
| Clinical condition | Conditioning of porcelain/ceramic surface | Conditioning of porcelain/ceramic surface |
| Time for use | 10-60 seconds | 20-40 seconds |
| Water Solubility | Soluble | Soluble |
| Contact with humanbody | Etching in vitro | Etching in vitro |
| Prescription/over-the-counter use | Prescription | Prescription |
| Physical form | Gel | Gel |
| Delivery form | Syringe | Syringe |
| Physical Properties | The subject device and the predicate device have substantially equivalent physicalproperties as they all conform to HUGE SOP. |
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The technological characteristics of the subject device are very similar to those of the predicate device. The subject device is a similar product, manufactured with similar materials and used in the same way by the same types of users and patient populations. The subject device and the predicate device have minor difference in Composition of Materials. However, the difference does not affect the intended use or substantial equivalence. Besides, other comparison items such as Clinical condition, Time for use, Water Solubility, Contact with human body, Physical form, Delivery form and Physical Properties, etc. are the same or very similar. And both of the subject device and the predicate device are supplied for prescription use.
8. Summary of Non-clinical testing
Through real-time stability testing, the shelf life of the subject device is reliable and effective within 2 years.
The physical properties of the subject device, including Thermostability, Hydrofluoric acid content, Rotational viscosity value and pH value, were determined and tested according to Internal standard SOP of the company, and the test results demonstrated the qualification and substantial equivalence when compared to the predicate device.
Additionally, the subject device is substantially equivalent to the predicate device that has been legally marketed already and with no clinical adverse events. The compositions of the subject device do not contain any non-conventional chemicals compared to the legally marketed predicate device. According to International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", the subject device does NOT contact the patient's body directly, and Biocompatibility Evaluation Endpoints are not applicable and biocompatibility tests are not required accordingly. And the biocompatibility analysis is sufficient to prove the safety of the subject device.
9. Summary of Clinical testing
Clinical test is not applicable.
10. Conclusions
Based on the indications for use, technological characteristics, performance testing and comparison to the predicate device, the subject device has been shown to be safe and effective for its intended use and the minor differences in composition of the predicate device affecting neither the general intended use nor substantial equivalence. Rizhao HuGe Biomaterials Company, Ltd. concludes that the subject device is substantially equivalent to the predicate
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device described herein.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.